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AZITHROMYCIN DIHYDRATE USP |
| Sr.No. | SAMPLE TEST | RESULT | STANDARD VALUE |
| 1. | Description | White Crystalline powder | White Crystalline powder |
| 2. | Identification by a.) T.L.C b.) I.R | Passes Passes | |
| 3. | Solubility | Passes | Soluble in Acetone, Chloroform, Methyl Chrolide, Ethyl Acetate, Ethanol, Methanol Dimethyl Formamide. |
| 4. | Moisture | 4.30% | Max 5.0% |
| 5. | Heavy Metal | Passes | Not > 0.0025% (25 ppm) |
| 6. | Residue on Ignition | 0.09% | Max 0.2% |
| 7. | Not > 0.0025% (25 ppm) | ||
| 6. | Residue on Ignition | 0.09% | Max 0.2% |
| 7. | Assay (on Dry Basis) Chemical Microbiological | 986 mcg /mg 986 mcg /mg | Not < 950 mcg /mg |
| 8. | Specific Rotation(on Dry Basis) | -46.55oC | Between -45oC to -49oC |
| 9. | Related Substance | Approx.1.0% | Max 3.0% |
| 10. | PH | 10.85 | Between 9 to 11 |
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